CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate)(十六)
ents in CLARINEX-D® 12 Hour Extended Release Tablets?
Active ingredients: desloratadine and pseudoephedrine sulfate
Inactive ingredients: hypromellose USP, microcrystalline cellulose NF, povidone USP, silicon dioxide NF, magnesium stearate NF, corn starch NF, edetate disodium USP, citric acid anhydrous USP, stearic acid NF and FD&C Blue No. 2 aluminum lake dye.
Manufactured by Schering Corporation, a subsidiary of Schering-Plough Corporation,
Kenilworth, NJ 07033 USA.
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Rev: Month/Year
© 2006, 2009, Schering Corporation. All rights reserved.
U.S. Patent Nos. 4,659,716; 4,863,931; 5,595,997; and 6,100,274
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
CLARINEX-D®
12 HOUR
(desloratadine 2.5 mg/
pseudoephedrine sulfate, USP 120 mg)
EXTENDED RELEASE TABLETS
Rx only
image of package label
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INGREDIENTS AND APPEARANCE
CLARINEX-D 12 HOUR
desloratadine and pseudoephedrine sulfate tablet, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5708(NDC:0085-1322)
Route of Administration ORAL DEA Schedule CV
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
DESLORATADINE (UNII: FVF865388R) (DESLORATADINE - UNII:FVF865388R) DESLORATADINE 2.5 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE 120 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
ALUMINUM OXIDE (UNII: LMI26O6933)
PRODUCT CHARACTERISTICS
Color blue, white Score no score
Shape OVAL Size 15mm
Flavor Imprint Code D12
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-5708-0 10 in 1 BOTTLE, PLASTIC
2 NDC:54868-5708-1 30 in 1 BOTTLE, PLASTIC
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021313 11/29/2006
LABELER - PHYSICIANS TOTAL CARE, INC. (194123980)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Physicians Total Care, Inc. 194123980 relabel, repack |
